A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety and Biomarker Effects of ALZ-801 in Subjects with Early Alzheimer’s Disease and APOE4/4 Genotype

  • End date
    Aug 31, 2024
  • sponsor
    Alzheon, Inc.
Updated on 24 June 2022
alzheimer's disease
mild dementia
cognitive assessment
Accepts healthy volunteers


This study is designed to evaluate the safety and efficacy of oral ALZ-801 in the treatment of early Alzheimer’s Disease (AD) with APOE4/4 genotype.


This phase 3, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of ALZ-801 in participants with early (prodromal to mild) AD and Mild Cognitive Impairment (MCI) due to AD. Eligible participants who are found to have APOE4/4 genotype as part of the study will be randomized to receive oral ALZ-801 or placebo in a ratio of 1:1 over a duration of 18 months. The efficacy of oral ALZ-801 on cognition in participants will be evaluated using the ADAS-Cog 13 assessment scale

Contact: Recruitment Team Member
Phone number: 571-418-0142

Condition Cognitive Impairment, Dementia, Alzheimer’s Disease, Mild Cognitive Impairment, Genetic Testing, Family History
Clinical Study IdentifierTX299666
SponsorAlzheon, Inc.
Last Modified on24 June 2022


Yes No Not Sure

Inclusion Criteria

Male or female between the ages of 50 and 80 years (inclusive) at the Screening – Part 1 Visit
Clinical diagnosis of MCI or Mild Dementia due to AD consistent with the National Institute on Aging-Alzheimer’s Association (NIA-AA) Working Group Criteria
Homozygous for the ε4 allele of the apolipoprotein E gene (APOE4/4)
Evidence of progressive memory loss over the last 12 months per investigator assessment

Exclusion Criteria

Brain magnetic resonance imaging (MRI) indicative of significant abnormality per central reader, other than AD related atrophy. Computed tomography (CT) scan acceptable for subjects who can not undergo MRI (CT is not allowed for subjects at sites in Germany)
Diagnosis of a neurodegenerative disorder other than AD
Diagnosis of major depressive disorder (MDD) within one year prior to the Baseline Visit (Visit 2)
Currently taking memantine or has taken memantine within 12 weeks prior to the Baseline Visit
History of cancer diagnosed and treated within the last 3 years (with exception of treated: basal cell carcinoma, cutaneous squamous cell carcinoma in situ, in situ or stage 1 prostate cancer, in situ cervical cancer, resected and cured early-stage cutaneous melanoma)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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